RECRUITING

The Gut Microbiome and Immunotherapy Response in Solid Cancers

Description

The aim of this study is characterize the gastrointestinal microbiomes of patient with solid cancer undergoing standard of care treatment with programmed cell death protein 1 (PD-1) /programmed cell death ligand (PD-L1) blockade.

Conditions

Cancer
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Related Conditions:

Cancer

Study Overview

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Study Details

Study overview

The aim of this study is characterize the gastrointestinal microbiomes of patient with solid cancer undergoing standard of care treatment with programmed cell death protein 1 (PD-1) /programmed cell death ligand (PD-L1) blockade.

The Gut Microbiome and Immunotherapy Response in Solid Cancers

The Gut Microbiome and Immunotherapy Response in Solid Cancers

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

Galveston

University of Texas Medical Branch, Galveston, Texas, United States, 77845

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Current diagnosis of malignant solid cancer that is nonresectable or metastatic.
  • 2. Ages 35 to 75 years.
  • 3. Treatment with immunotherapy, specifically programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) inhibitor, for at least 3 months but less than 24 months (except for previously responsive subjects re-enrolling as non-responsive patients).
  • 4. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.
  • 5. Participant is willing and able to give informed consent for participation in the study
  • 1. Significant heart, liver, blood or respiratory disease.
  • 2. Current diagnosis of HIV, Hepatitis B or Hepatitis C.
  • 3. History of heart disease.
  • 4. Uncontrolled diabetes mellitus.
  • 5. Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease.
  • 6. Females who are pregnant or lactating.
  • 7. Treatment with chemotherapy within the past 2 years.
  • 8. Treatment with kinase inhibitors within the past 3 months.
  • 9. Previous radiation therapy for brain metastases.
  • 10. Other medical condition or medication administration deemed exclusionary by the study investigators.

Ages Eligible for Study

35 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Medical Branch, Galveston,

Melinda Sheffield-Moore, PhD, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

2025-12-30